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Medical deviceProductC a t a l o g u e

3P R O D U C T L I S T


History

Activities of Samyang

R&D

Products

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2005

Relocation of Daejeon R&D Center and Seoul HQ to Samyang Discovery Center in Pangyo

Launched the Oxidized Regenerated Cellulose Adhesion Barrier InterGuard®Launched the Oxidized Regenerated Cellulose hemostat SurgiGuard®

EU GMP for API(extention) German AuthoritiesLaunched Endoscopic Sugical Loop, Neosorb® Loop & Monosorb® Loop

Samyang Biopharm and Samyang Genex Bio merged into one companyDrug-contained suture (Neosorb® Plus) was approvedLaunched the painkiller Fentaderm® patchLaunched the oral-disintegrating drug antinauseant Imestop®Launched the anticancer drug Nanoxel® M Injection

2012 12 Hit 100,000 km annual surgical suture sales (in terms of bulk volume)Launched the anticancer adjuvant Zolenic® InjectionThe anticancer drug Nanoxel®M Injection was approvedLaunched the surgical sutures Monosorb® Plus and Monofast® PlusThe antinauseant Emestop® Injection was approvedDesignated as an innovative pharmaceutical company by the Ministry of Health and WelfareSamyang Genex spun off Samyang Genex Bio (physical division)

Samyang Group transformed into a holding company structure Samyang Biopharmaceuticals Corporation established“Research Collaboration Agreement” reached with Takeda Pharmaceutical co., Ltd. for discovering a novel DDS platform technology for RNAi therapeutics

Australian TGA GMP certification for patch products received

Launched Antibacterial absorbable braided suture material, Neosorb PlusIran GMP certification for pharmaceuticals received

Docetaxel-PNP receives IND approvalNanoxel injection(docetaxel) approvedNicostop Gum approvedGenexol-PM approved in IndiaGenexol-PM receives IND approval (phase II on ovarian cancer)Genexol-PM approved in VietnamGenexol-PM approved in PhilippineAnti-adhesion Barrier Poligogel receives IND approvalGenexol approved in SerbiaGenexol-PM receives IND approval (phase I on ovarian cancer)

Docetaxel-PM receives IND approvalCapsaicin plaster IND approval Loratadine FDT approvedSuture Neosorb approved

Partially Absorbable Surgical mesh Proflex approvedGenexol-PM wins Korea New Drug Award GENEXOL-PM™ (next generation anti-cancer agent using Paclitaxel, injection) marketed in Korea

Daedeok pharmaceutical plant extended Genexol-PM wins Health industry & technology awardLaunched Absorbable braided suture material, NeosorbMedical management information system built

Nicostop troche approvedNexatin injection(oxaliplatin) approvedLaunched Absorbable monofilament suture material, Monofast“Business Agreement” reached with Akina, Inc. of the U.S. on Cetirizine FDT

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HistoryContents



Related businesses

Samyang Corporation

Mixed feeds Trading

Samyang Data Systems

Information technology

Samyang Entech Machinery Environment

Pharmaceutical

SamyangBiopharm

Patches Medical devices

Anti-cancers drugs

Chemicals

SamyangCorporation

Engineering plastics

Industrial fiber PET bottles PET bottle

recyclingIon exchange

resins

Samnam Petrochemical

TPA

SamyangKasei

Poly-carbonate

SamyangEngineering

Plastics (Shanghai)

Engineering Plastics

Samyang EMS Photoresist

Foodstuffs

SamyangCorporation

Sugar Flour Vegetable oils Baking & Batter mixes

Margarine & Shortening Olive oil Bakery

ingredientsHigh intensity

sweetener

SamyangGenex

Starch Corn sweeteners Polyols

Functional food

ingredients

SamyangMilmax

Flour Naaking & Batter mixes

SamyangWelfood

Margarine & shortening Vegetable oils

SevenSprings

Family restaurant

SamyangF&D

Bakery Cafe

SamyangGenex food

(Qinhuangdao)

Corn sweeteners

2004

2003

2002

2001

2000

1999

1998

1997

1996

1995

1994

1993

1992

“R&D Agreement” reached with Hyundai Pharmaceutical of Korea on Cetirizine Hydrochloride FDT

Phase II clinical trials of Genexol PM on breast cancer II initiated at Asan Medical Center, etc.

Suture Monosorb-Pro approved

Genexol Injection certified as effective in gastric cancer treatment

“R&D Agreement” reached with Akina, Inc. of the U.S.

Phase II clinical trials of Genexol PM on non-small cell lung cancer initiated at Seoul National University Hospital, etc.

Phase II clinical trials of Genexol PM on breast cancer I initiated at Seoul National University Hospital, etc.

Genexol Injection certified as effective in ovarian cancer treatment

“R&D Agreement” reached with Lavipharm of Greece and technical Transfer of Nicostop completed

Genexol Injection certified as effective in lung cancer treatment

Pharmaceutical research corporation established in Utah Samyang Research Corporation(SRC)

Genexol-PM receives U.S. IND approval

100 mg Genexol-PM Injection approved

“Business Agreement” reached with Akina, Inc. of the U.S.

Genexol-PM Injection approved

Genexol Injection certified as effective in breast cancer treatment

“R&D Agreement” reached with Transform Pharmaceuticals, Inc. of the U.S.

“Business Agreement” reached with Transform Pharmaceuticals, Inc. of the U.S.

Surgisorb and BioMesh acquire CE mark

Three R&D Agreements reached with MacroMed, Inc. of the U.S. on hGH, pGH, Tramadol, and G-CSF

Medical devices acquire ISO 9001 & EN 46001 certification

BioMesh approved

KGMP certification for medical device received

Launched Absorbable monofilament suture material, Monosorb

Genexol Injection approved and released (Jun 1, 2001)

Reumastop Plaster approved

Surgisorb, an absorbable suture product, approved and released (Dec 1, 1998)

Nicostop patches approved

Trisorb wins Jang Young Shil Award

Launched 1st Absorbable braided suture material, Trisorb

KGMP certification for pharmaceuticals received

“Business Agreement” reached with AmCyte, Inc. of the U.S.

“Business Agreement” reached with VivoRx Pharmaceutical, Inc. of the U.S.

“R&D Agreement” reached with MacroMed, Inc. of the U.S. and Gene Delivery System developed

“R&D Agreement” reached with TheraTech, Inc. of the U.S. on Combitran-MTX

“R&D Agreement” reached with TheraTech, Inc. of the U.S. on Estran-MTX

Medical suture products win patented technology award

“R&D Agreement” reached with TheraTech, Inc. of the U.S. on Androderm-LRS and Angiderm-MTX patches

“Business Agreement” reached with MacroMed, Inc. of the U.S.

Medical suture products granted the Korea Good Technology mark

Pharmaceutical Research Center established

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Activities of SamyangHistory


Samyang first established R&D center in 1979 and moved to its ultra-modern central R&D center in Daedeok science town in 1993. As part of effort to become a truly world class research center, academicians and scientists recognized in their fields from Korea and abroad were invited for Scientific Advisory Board(SAB).

Samyang decided to put its R&D resource to conduct research in the field of drug delivery system and biotechnology.

Samyang’s involvement in the research to develop novel drug delivery system began when it decided to make equity participation in Thera Tech U.S.A ; a company dedicated to the development of transdermal drug delivery systems. Since then Samyang has been nurturing its own in-house research to become a world class center for drug delivery system research.

Samyang’s expertise in polymer chemistry and its dedication to use proprietary biopolymer technologies to develop novel drug delivery systems has resulted in development of technology platforms with applications in cancer therapy, acute/chronic pain management, smoking cessation, hormone therapy, surgical wound management and more. The formulations developed cover various type of parenterals (enhanced bioavailabilty, sustained release and long articulating particles injections), transdermal patches, rapid dissolution tablets, colon targeting oral formulations, various types of suture materials and needles.

While focusing efforts on the in-house development of novel drug delivery system, we have continued to expand our technology portfolio. Samyang has invested in several new development stage companies that have proprietary technologies for future development of drug delivery systems. In line with its commitment to become a world class drug delivery system developing company, Samyang is prudently pursuing rigorous in-house R&D programs, internal collaboration and strategic alliances.

Samyang’s biotechnology related research activities are conducted at the Samyang Genex Research Institute located within its R&D center. The institute is engaged in plant-biology, therapeutic protein, gene-therapy research projects.

Plant biology research includes development plant cell culture technology to produce useful secondary metabolites from plants. The institute successfully produced paclitaxel, an important anti-cancer drug, by plant cell culture technology. The technology has been successfully scaled up to commercial scale and a dedicated plant is producing high quality paclitaxel bulk under cGMP and US FDA guidelines.

Samyang’s biotechnology-related research activities are conducted at Samyang Genex Biotechnology Research Center located within Samyang Group R&D Complex. Biotechnology Research Center is engaged in the plant biotechnology, microbial fermentation, and organic synthesis research. Researches on Plant Biotechnology involves development of plant cell culture technology for producing useful secondary metabolites from plant cells. Paclitaxel, an important anti-cancer drug, was the first commercial product of plant cell culture technology.

Samyang Genex is now producing the best quality paclitaxel at its Daejeon plant, which is compliant to cGMP (cGMP: current good manufacturing practice, US compliance) and has been certified by EU Authority (Germany). Samyang Genex’s paclitaxel has recently been approved for CEP from European Medicinal Agency. Microbial fermentation research focuses on the strain and process development of useful therapeutic intermediates and APIs (Active Pharmaceutical Ingredients). Recently, the Center has expanded its research scope to organic synthesis. The Center plans to expand the portfolio of anticancer therapeutics by combining intermediate production and semi-synthesis to produce a lot of interesting APIs.

P R O D U C T s

R&D

Trisorb®

Trisorb® II

Trisorb® Rapid

Trisorb® Plus

Neosorb®

Neosorb® Rapid

Neosorb® Plus

Monosorb®

Monosorb® Plus

Monofast®

Monofast® Plus

Monolene®

Surgisorb®

Proflex® Mesh

SurgiGuard® M

SurgiGuard®

InterGuard®

Biomesh®

8 9P R O D U C T L I S T P R O D U C T L I S T

Description Coated Synthetic Absorbable Braided PGA Suture material

Non-sterile bulk strand

IndicationStrand for further processing to finished sterilized sutures for human and veterinary use

Characteristics· Compliance with the requirements of USP and EP

· High tensile strength

· Excellent handling and knotting characteristics

- Smooth tissue passage

- Easy knotting and tie down

- Excellent knot security

· Reliable absorbability

specifications & Package

S y n t h e t i c A b s o r b a b l e B r a i d e d S u t u r e M a t e r i a l

IsO 13485Certified Quality System


Description Coated Synthetic Absorbable Braided PGA Suture material



Characteristics· Higher tensile strength and better handling than Trisorb

· Compliance with the requirements of USP and EP









Trisorb® IITrisorb®

Size Color & Packaging LengthCoating Materials

USP Metric 500m 1,000m

3,4 7,8

Ca-Stearate&

PCL

2 6

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5

6-0 1

7-0 0.7

8-0 0.5



2 6

Ca-Stearate&

PGA-PLA

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5

6-0 1

7-0 0.7

8-0 0.5


F a s t A b s o r b a b l e B r a i d e d S u t u r e M a t e r i a l

Description Coated Synthetic Fast Absorbable Braided PGA Suture

IndicationSuperficial skin closure, scalp plastic surgery, episiotomy wound healing or oral mucosa.


· Reliable absorbability. (lose its breaking strength 9~11days after application)

· Available in the undyed form


Antibacterial Synthetic Absorbable Braided Suture Material

DescriptionCoated Synthetic Absorbable Braided PGA Suture material

Antibacterial agent contained suture











Trisorb® PlusTrisorb® Rapid





1 5

Ca-Stearate&

PCL

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5

6-0 1



2 6

Ca-Stearate&

PGA-PLA&

CHA

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5



Description Coated Synthetic Absorbable Braided PGA-PLA(90:10) Suture material











F a s t A b s o r b a b l e B r a i d e d S u t u r e M a t e r i a l

DescriptionCoated Synthetic Fast Absorbable Braided PGA-PLA(90:10) Suture material

IndicationSuperficial skin closure, scalp plastic surgery, episiotomy wound healing or oral mucosa.


· Reliable absorbability. (lose its breaking strength 5~8days after application)

· Available in the undyed form


Neosorb® RapidNeosorb®





2 6

Ca-Stearate&

PGA-PLA

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5

6-0 1

7-0 0.7

8-0 0.5



2 6

Ca-Stearate&

PGA-PLA

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5

6-0 1


Antibacterial Synthetic Absorbable Braided Suture Material

Description Coated Synthetic Absorbable Braided PGA-PLA(90:10) Suture material












Description Synthetic Absorbable PDO Monofilament Suture material



Characteristics· Compliance with the requirements of EP

· Lower Incidence of Infection and Trauma due to Smooth Surface

· Smooth tissue passage

· Predictable loss and Higher strength compared to Catgut


S y n t h e t i c A b s o r b a b l e M o n o f i l a m e n t S u t u r e M a t e r i a l

Monosorb®Neosorb® Plus





2 6

Ca-Stearate&

PGA-PLA&

CHA

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5



2 6

N/A

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5

6-0 1

7-0 0.7


Antibacterial Synthetic Absorbable Monofilament Suture Material

DescriptionSynthetic Absorbable PDO Monofilament Suture material



IndicationStrand for further processing to finished sterilized sutures for human and

veterinary use






Description Synthetic Fast Absorbable PGA-PCL(75/25) Monofilament Suture material




· Excellent handling properties : Flexible, easy to tie





F a s t A b s o r b a b l e M o n o f i l a m e n t S u t u r e M a t e r i a l

MonoFast®Monosorb® Plus





2 6

CHA

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5


USP Metric 250m

2 6

N/A

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5

6-0 1


Antibacterial Synthetic Absorbable Monofilament Suture Material

DescriptionSynthetic Fast Absorbable PGA-PCL(75/25) Monofilament Suture material





· Excellent handling properties : Flexible, easy to tie





MonoFast® Plus


Description Synthetic Non-absorbable Polypropylene (PP) Monofilament Suture material, Non-sterile bulk strand



· Excellent handling properties : flexible, easy to tie



· High strength



Non-absorbable Polypropylene Monofilament Suture Material

Monolene®


USP Metric 250m

2 6

CHA

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5



1 5

N/A

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5

6-0 1

7-0 0.7

8-0 0.5


Us FDA Approved510(K) No. K984374


CE Mark Approved

1023

Surgisorb®

S y n t h e t i c A b s o r b a b l e S t e r i l e S u t u r e s

Description Sterile, ready to use coated synthetic bioabsorbable PGA sutures (with and without needle)

IndicationClosure of wounds or vessels

Characteristics· Comply with USP and EP requirements

· Reliable retention strength

- Average 75% at 14 days (in vitro, USP 2-0)

- Predictable absorption (loss of mass) in 60 to 90 days

· Available in violet or undyed (beige) color

· Supplied with one or three dozen in a carton

specifications

PolypropyleneNon-absorbable part

PGA-PCL(75/25) CompositeAbsorbable part

PolypropyleneNon-absorbable part

PGA-PCL(75/25) CompositeAbsorbable part

S y n t h e t i c P a r t i a l l y A b s o r b a b l e S u r g i c a l M e s h

Description Synthetic Partially Absorbable Polypropylene/PGA-PCL(75/25) Composite Surgical Mesh

Non-sterile/Sterile

IndicationSurgical mesh for repair of hernias or other soft tissue defects

Characteristics· Lightweight Mesh (PP amount <30g/m2) with excellent handling characteristics

- Proper initial stiffness like heavyweight mesh

- Proper burst strength with minimized amount of PP

· Segmented-pie monofilament structure

- Excellent flexibility after absorption (Soft mesh) comparing to other products

- Reduced risk of infection comparing with multifilament products

- Minimized pain and discomfort

· Better tissue attachement due to large pores

· Violet strips help accurate mesh positioning

· Reliable materials used for surgical sutures (PP, PGA-PCL(75/25))


Proflex® Mesh


Size (cm) Packaging Unit

Non-Sterile Bulk Material Sterile Finished, Packaged Product

6 X 11 15pcs/Pouch 3pcs/Carton



SizeColor

Suture Length & Needle

Coating MaterialsUSP Metric

2 6

Various typesCa-Stearate

&PGA-PLA

1 5

1-0 4

2-0 3.5

3-0 3

4-0 2

5-0 1.5

6-0 1

7-0 0.7

8-0 0.5


Type Size (cm) Packaging Unit

Original

5 X 7.5 12pcs/Carton

5 X 35 12pcs/Carton

10 X 20 12pcs/Carton

1.25 X 5 12pcs/Carton

Fabric

5 X 7.5 12pcs/Carton

7.5 X 10 12pcs/Carton

15.2 X 22.9 10pcs/Carton



Fibrillar




Non-Woven




DescriptionAbsorbable knitted fabric composed by ORC (Oxidized Regenerated Cellulose)

Non-Sterile Bulk Material

IndicationSurgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage

Characteristics· Compliance with the requirements of USP

· Plant-based product with minimal tissue reaction

· Antimicrobial effect with low pH

· Typical absorption in 2 weeks



Sterile Finished, Packaged Product

IndicationSurgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage

Characteristics· Compliance with the requirements of USP

· Plant-based product with minimal tissue reaction

· Antimicrobial effect with low pH

· Typical absorption in 2 weeks


O x i d i z e d r e g e n e r a t e d c e l l u l o s e h e m o s t a t O x i d i z e d r e g e n e r a t e d c e l l u l o s e h e m o s t a t

SurgiGuard® M SurgiGuard®

Type Size (cm) Packaging Unit

Original 25 X 70 3pcs/Pouch

Fabric 15.2 X 22.9 15pcs/Pouch

Fibrillar 23 X 25.5 1pcs/Pouch

Non-Woven 10.5 X 25.5 4pcs/Pouch



CE Mark Approved

2265


Us FDA Approved510(K) No. K990363


CE Mark Approved

1023

Description Yellowish, white, microporous and embossed membrane

Made of biodegradable polyglycolide, polylactide and d, ℓ- lactide / glycolide copolymer

IndicationIn severe cases of periodontal disease where patients are the risk of losing teeth

To restore the periodontal attachment apparatus that anchors teeth to the bone

Characteristics· Good biocompatibility · Good space making

· Rapid tissue incorporation · Easy clinical manageability

· Good cell-occlusiveness

specifications

Code Configuration Usage

DMB 1000 Single tooth narrow

DMB 2000 Single tooth wide

DMB 3000 Wraparound

DMB 4000 Interproximal

DMB 7000For use on dental implant

DMB 8000

Tooth

EpithelialTissue

Periodontalligament

Connectivetissue

Alveolarbone

BioMesh

GTR therapy using BioMesh

B i o d e g r a d a b l e G T R B a r r i e r

BioMesh®

O R C A d h e s i o n B a r r i e r


Non-sterile/ Sterile

IndicationReducing the incidence of postoperative adhesions

Characterisctics· Oxidized Regenerated Cellulose is proved by FDA as anti-adhesion material

· Plant–based product with minimal tissue reaction

· Serves a solid synthetic membrane to physically separate tissues and organs during healing. Suitable to wrap organs

· Process of gelation starts within several days after implantation with the following complete degradation and absorption at 4 weeks


InterGuard®


Size (cm) Packaging Unit

Non-Sterile Bulk Material Sterile Finished, Packaged Product

7.5 X 10 20pcs/Pouch 10pcs/Carton

12.5 X 15 20pcs/Pouch 10pcs/Carton


Memo

www.samyangbiopharm.com/eng

samyang Biopharmaceuticals Corporation6F, 295, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, KoreaT. 82-2-2157-9833 F. 82-2-2157-9062

MD Plant, Medical Devices55, Munpyeongseo-ro 18beon-gil, Daedeok-gu, Daejeon, Korea

samyang Biopharmaceuticals R&D Center5F, 295, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea

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